Kornimate/medical-research-clean huggingface dataset:
social norms, messengers, and processing fluency to increase hypertension medication adherence

Conditions: Medication Adherence; Hypertension

Summary: medicare advantage beneficiaries ages 65-79 and insured by humana with at least two unique fills of hypertension medication within the 2023 calendar year and adherence level between 60 and 85% will be identified using humana medicare advantage claims data. individuals meeting these inclusion criteria will be included and, with an institutional review board approved waiver of informed consent, will be randomized to one of 6 mailed messages or control (no message). the messages will be sent by humana and use different behavioral techniques (social norms, messenger effects, and/or processing fluency) providing their medication refill score. humana will send a second message within 60 days of the first message noting any changes in the refill score. the primary outcome will be the average end-of-year adherence in each arm. a secondary outcome will be the proportion of study participants with end-of-year adherence greater than or equal to 80%. the study team's hypothesis is that messages using dynamic social norms, messenger effects, and processing fluency in combination will more effectively increase average end-of-year adherence level compared to usual care. humana will conduct all study participant outreach and data analyses, which will be performed using routinely collected insurance claims data. regulatory oversight is conducted using humana's centralized institutional review board (irb) of record. the work completed by humana study staff is funded by humana, inc. dr. choudhry and his colleagues (including subaward recipients ideas42 and tuck school of business at dartmouth) will provide technical and subject matter expertise related to study research design and implementation, protocol design, statistical analysis, publication (abstract, poster, manuscript) preparation and/or review, and assistance throughout the peer review process including revisions and additional analyses if necessary for this project. the work completed by study staff at brigham and women's hospital, ideas42, and tuck school of business at dartmouth is funded by nia.


Eligibility criteria:
inclusion criteria: * medicare advantage beneficiary insured by humana * between the ages of 65 and 79 * having at least two unique fills of any class of hypertension medication within the calendar year (2023). * adherence level (as measured by the proportion of days covered \[pdc\] metric) between 60% and 85% exclusion criteria: * beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research
myopia control using bright light therapy, myopic defocus and atropine

Conditions: Myopia

Summary: the purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

the present study is a multi-arm randomised clinical trial with a 24-month duration. subjects will be healthy hong kong chinese schoolchildren with low to moderate myopia. the aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (blt) and myopic defocus is more effective than monotherapy. study population seven hundred and sixty hong kong chinese children (152 in each) of a. control group, b. blt only group, c. blt and defocus incorporated multiple segments (dims) group, d. blt and atropine 0.01% group) and e. atropine 0.01% group aged 7-12 years old will be recruited. they must not have had prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. they must not have allergy to atropine. the eligible subjects will be randomly assigned into one of the four groups. their cycloplegic refraction and axial length will be monitored every six months for 2 years. the changes in refractive errors and axial length between groups will be compared.

Eligibility criteria:
inclusion criteria: * myopia of at least -0.75d (spherical equivalent) in both eyes * age at enrolment: 7-12 year; hong kong chinese * astigmatism and anisometropia: 1.50d or less * spectacle corrected monocular visual acuity (va): 0.0 logmar or better * parents' understanding and acceptance of random allocation of grouping and masking * able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily. exclusion criteria: * eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) * previous intraocular or corneal surgery * systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, down syndrome, etc.) * allergy to atropine * previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/pal/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear) * previous or current participation in myopia control studies

Keywords: myopia control bright light myopic defocus atropine
prospective study on the risks of dengue fever for the fetus.

Conditions: Dengue Fever

Summary: dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the flavivirus genus of the flaviviridae family like zika. its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in europe. current data on the consequences of dengue fever on the fetus are incomplete. the risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. however, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue. regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant patients * major * affiliated with social security * symptomatic or pauci-symptomatic dengue * biological confirmation of dengue fever by dengue positive pcr or igm positive during the current dengue episode exclusion criteria: * multiple pregnancy * patient's refusal * protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)

Keywords: dengue fever ; pregnancy
to demonstrate the relative bioavailability of alprazolam tablets, 1 mg

Conditions: Anxiety

Summary: to demonstrate the relative bioavailability of alprazolam tablets, 1 mg.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
a study to evaluate the efficacy and safety of biib093 in participants with brain contusion

Conditions: Brain Contusion

Summary: the primary objective is to determine if biib093 reduces brain contusion expansion by hour 96 when compared to placebo. the secondary objectives are to evaluate the effects of biib093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of biib093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if biib093 improves survival at day 90 when compared to placebo.


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling \>3 ml in volume per investigator assessment of baseline non-contrast computed tomography scan (ncct) at screening. * a score of 5 to 15 on the glasgow coma scale (gcs). * functionally independent, in the opinion of the investigator, prior to index head injury. key exclusion criteria: * in the judgment of the investigator, participant is likely to have supportive care withdrawn within 24 hours. * indication for immediate evacuation of iph or dc. * clinical signs of brainstem herniation, in the opinion of the investigator. * ncct or magnetic resonance imaging (mri) evidence of penetrating brain parenchyma. cerebrospinal fluid leak in isolation is not exclusionary unless evidence of parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed skull fracture). * any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination. * presence of concomitant spinal cord injury as assessed by imaging and clinical examination. * life-threatening or nonsurvivable polytrauma, per investigator's judgment. * use of novel oral anticoagulants (noacs; including direct thrombin inhibitors such as dabigatran, or factor xa inhibitors such as rivaroxaban or apixaban), in preceding 3 days prior to the injury, if known. note: other protocol defined inclusion/exclusion criteria may apply.
systematic support for relatives of palliative care patients

Conditions: Prolonged Grief Disorder

Summary: the primary purpose of this study is to validate the prognostic screening tool from the aarhus bereavement study (tabs) and to implement a systematic support for relatives of palliative care patients in order to prevent the development of prolonged grief disorder. depending on their identified support needs, the relatives are offered different interventions. it is evaluated whether this procedure of screening and intervening are able to reduce the risk of developing prolonged grief disorder.

primary outcome: identification of the support needs of relatives of palliative care patients secondary outcome: evaluation of the initiated interventions and whether these are able to reduce the risk of developing prolonged grief disorder participants: relatives (age 18-90) of patients affiliated with specialized palliative care in the capital region of denmark. the relatives will complete a survey and prognostic screening tool at respectively 2 weeks (t1) and every 6 months (t2) from the time that the patients is affiliated to the specialized palliative care and until the death of the patient. this will happen regardless the status of the patient - that is, whether or not the patient continues being affiliated with specialized palliative care, or the patient is being referred to another palliative care units or doesn't need palliative care anymore. furthermore the relatives will complete a follow-up survey and the diagnostic questionnaire pgd-13 at respectively 6 months (t3) and 18 months (t4) after the death of the patient (post loss). it will be evaluated whether there are any diffences in the grief symptoms of relatives of patients with a malign versus non-malign disease. it will also be evaluated whether there is an association between the intervention the relatives received from the palliative care unit at rigshospital and their grief symptoms post loss.

Eligibility criteria:
inclusion criteria: * relatives of palliative care patients with relation to department of palliative care, (rigshospitalet) * relatives identified by the patient exclusion criteria: * relatives who do not read or understand danish * relatives who are cognitive disabled

Keywords: palliative care screening tool assessment tool relatives support needs anticipatory grief palliative patients caregivers
onco-geriatric database of patients with pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: this data base has been set in order to gather oncogeriatric information from elderly patients with pancreatic cancer who underwent an oncogeriatric evaluation. oncogepan database gathers data from deux institutions (institut paoli-calmettes and assistance publique des hôpitaux de marseille) involved in marseille siric (integrated cancer research site).


Eligibility criteria:
inclusion criteria: * age\>70 years * oncogeriatric evaluation done exclusion criteria: * patient refusal to participate in the study

Keywords: oncogeriatric evaluation pancreatic cancer database
walnuts and healthy aging

Conditions: Age Related Cognitive Decline; Age Related Macular Degeneration

Summary: this will be a systematic investigation of the role of walnuts in preventing or slowing age related cognitive decline and age related macular degeneration. 700 subjects will be recruited between 2 sites, loma linda university in california, usa and hospital clinic in barcelona, spain. participants will be randomly assigned to either the walnut group or the control group for a 2 year intervention. baseline and annual data will be collected and analyzed.

epidemiological studies suggest that nutrients such as n-3 polyunsaturated fatty acid, antioxidants and b-vitamins may protect against age related cognitive decline. small human studies have shown beneficial effects of polyphenol rich foods on cognition and age related macular degeneration. walnuts are a rich source of n-3 polyunsaturated fatty acid, alpha-linolenic acid, antioxidants, polyphenols and other bioactive compounds. a 2-year intervention will be conducted with healthy, elderly subjects to investigate the role of walnuts in preventing or slowing age related cognitive decline and age related macular degeneration. 350 subjects, age 63 to 79 years, will be recruited at each of 2 sites, loma linda university in california and hospital clinic in barcelona. participants will be randomly assigned to one of two groups: walnut group (habitual diet with 1 or 2 oz/d walnut supplement) or control group (habitual diet only). at baseline and yearly, cardiometabolic risk factors, red blood cell membrane fatty acids, urinary polyphenols and biomarkers of inflammation and oxidation will be measured. eye exam, blood pressure and cognitive function tests will be measured at the beginning and end of 2 years. at the barcelona site only, participants will be given a brain mri and carotid ultrasound. descriptive results will be reported as mean plus/minus standard deviation. primary analysis will be carried out on the basis of groups as randomly assigned. results will be presented as appropriate effect sizes with a measure of precision (95% ci). analysis of covariates gender, age, educational status will be conducted.

Eligibility criteria:
inclusion criteria: * 63 to 79 years old * healthy men and women * able to attend clinic at a study sites exclusion criteria: * illiteracy or inability to understand the protocol * unable to undergo neurophysiological tests * morbid obesity (bmi greater than or equal to ≥ 40 kg/m2) * uncontrolled diabetes (hba1c\>85) * uncontrolled hypertension * prior cerebrovascular accident * any relevant psychiatric illness, including major depression * advanced cognitive deterioration, dementia * other neurodegenerative diseases (i.e. parkinson's disease) * any chronic illness expected to shorten survival (heart, liver, cancer, etc) * bereavement in the first year of loss * bad dentures unless fixable dental prostheses are used * allergy to walnuts * customary us of fish oil or flaxseed oil supplements * eye related exclusion criteria

Keywords: walnuts age related cognitive decline age related macular degeneration healthy elderly subjects
safety and pharmacokinetics study of odm-201 in castrate resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate safety, tolerability and pharmacokinetics of odm-201 in patients with castrate resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed adenocarcinoma of prostate * ongoing androgen deprivation therapy with a lhrh analogue or antagonist or bilateral orchiectomy * progressive metastatic disease * adequate bone marrow, hepatic, and renal function exclusion criteria: * known metastases in the brain * history of other malignancy within the previous 5 years * known gastrointestinal disease or procedure that affects the absorption * not able to swallow the study drug
efficacy and safety of 4.5mg peg-rhg-csf per cycle in preventing neutropenia after intensive chemotherapy for breast cancer

Conditions: Breast Cancer; Neutropenia

Summary: this is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddec adjuvant chemotherapy, accepting peg-rhg-csf as primary prevention of neutropenia.


Eligibility criteria:
inclusion criteria: * breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddec regimen. * ecog\<=1 * expected survival is greater than 6 months * qualified for chemotherapy，wbc\>=3\*109/l, anc\>=1.5\*109/l, hb\>=80g/l, plt\>=80\*109/l. with no bleeding tendency or systemic hematology disorder symptoms. * no obvious ekg abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction. * liver function, alt and ast should less than 2.5 times of the upper limit. * renal function, cr and bun should less than 1.5 times of the upper limit. * subjects voluntarily participate in this study and sign informed consent. exclusion criteria: * total amount of doxorubicin used in previous chemotherapy\>240mg/m2, or epirubicin\>360mg/m2 * has received hematopoietic stem cell transplantation or bone marrow transplantation * other drugs are currently in clinical trials * there are currently hard-to-control infections, body temperature is higher than 38 degrees. * received peg-rhg-csf treatment before enrollment * received chemotherapy in 4 weeks before enrollment * patients with any visceral metastasis * patients with severe heart, kidney, liver or any other important organs chronic diseases * patients with severe uncontrolled diabetes * patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli * suspected or real drug users, substance abusers, alcoholics * pregnant or lactating women * severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
afatinib in combination with cisplatin or carboplatin + pemetrexed in patients with egfr-mutant lung cancers undergoing definitive chemoradiation

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this phase i study is to test the safety of combining afatinib with standard chemotherapy and radiation. the drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. this study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. these treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.


Eligibility criteria:
inclusion criteria: * unresectable or inoperable, stage iii or locoregional recurrence without evidence of distant, metastatic disease * pathologic confirmation of nsclc at mskcc * documentation of a sensitizing egfr mutation * age ≥ 18 years * no contraindication to definitive thoracic radiation therapy with concurrent chemotherapy adequate organ function as defined by: * calculated creatinine clearance≥ 45 ml/min (by cockcroft-gault) * total bilirubin less than 1.5 x uln (unless known gilbert's disease) and ast/alt less than 3 x uln * absolute neutrophil count greater than 1500/mm3 * platelet count greater than 100,000/mm3 * women of childbearing age must have a negative blood pregnancy test * men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months there after exclusion criteria: * prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable) * ineligible for cisplatin or carboplatin per medical oncologist * ineligible for pemetrexed per medical oncologist * greater than minimal, exudative, or malignant pleural effusion * calculated creatinine clearance by cockcroft \& gault method ≤45 ml/min * unstable congestive heart failure * ejection fraction \<50% as assessed by muga or echocardiogram * interstitial lung disease * patient requiring on-going treatment with a potent inhibitor (cyclosporin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital with quinidine, ritonavir, valspodar, verapamil) or inducer of p-gp (st. john's wort or rifampin) * women who are breastfeeding

Keywords: afatinib cisplatin carboplatin pemetrexed radiation therapy egfr mutation 12-279
predictive value of pet/ct for efficacy of neoadjuvant immunotherapy in non-small cell lung cancer

Conditions: Lung Cancer (NSCLC); Neoadjuvant Immunotherapy

Summary: the aim of this study was to investigate the enhancement of fapi pet/ct metabolic parameters in predicting the efficacy performance of neoadjuvant immunotherapy using the pcr status of surgically resected specimens of lung cancer as the gold standard.


Eligibility criteria:
inclusion criteria:(1) aged 18 years or older; (2) pathological diagnosis of non-small cell lung cancer; (3) lesions resectable by surgery; (4) no egfr mutation or alk mutation; (5) eligible for indications of neoadjuvant immunotherapy for lung cancer. - exclusion criteria:(1) patients who had used any other antitumor drugs or radiotherapy; (2) comorbidities with other malignant neoplastic diseases or severe cardiovascular diseases; (3) uncontrollable diabetes mellitus or fasting blood glucose level higher than 11 mmol/l on the test day; (4) pregnancy or recent pregnancy plan; (5) distant metastasis. -
genetic and electrophysiologic study in focal drug-resistant epilepsies

Conditions: Refractory Focal Epilepsy; Focal Cortical Dysplasia; Hemimegalencephaly; Tuberous Sclerosis; Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE)

Summary: brain somatic mutations in genes belonging to the mtor signaling pathway are a frequent cause of cortical malformations, including focal cortical dysplasia or hemimegalencephaly. the present study aims to search for brain somatic mutations in paired blood-brain samples and perform functional validation in children with drug-resistant focal epilepsy


Eligibility criteria:
inclusion criteria: * children with focal drug-resistant epilepsy including focal cortical dysplasia, hemimegalencephaly, tuberous sclerosis, mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (moghe), hypothalamic hamartomas, sturge-weber syndrome, rasmussen encephalitis, gliomas) * their parents who have signed informed consent 1) for their child's participation (for parents) and 2) for themselves * social security coverage or foreign regime recognized in france exclusion criteria: * refusal to participate in the study * contraindication to anaesthesia, to mri or to surgery * no medical insurance coverage

Keywords: refratory focal epilepsy focal cortical dysplasia cortical malformation hemimegalencephaly tuberous sclerosis mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (moghe)